Module 1: Introduction to Biosafety and Biosecurity Principles

• History and evolution of biosafety and biosecurity

• Overview of international frameworks (WHO, CDC, ISO 35001, BMBL)

• Key terminologies, risk groups, and containment principles

• Hands-on Exercise: Mapping biosafety levels (BSL-1 to BSL-4) in sample facilities

Module 2: Biological Risk Assessment and Hazard Identification

• Principles of biological risk assessment

• Identifying potential hazards and exposure routes

• Risk evaluation and mitigation techniques

• Hands-on Exercise: Conducting a biosafety risk assessment for a simulated lab

Module 3: Containment and Laboratory Design Requirements

• Principles of primary and secondary containment

• Design features of BSL laboratories

• Facility layout, airflow control, and HEPA filtration systems

• Hands-on Exercise: Reviewing a laboratory floor plan for compliance gaps

Module 4: Laboratory Equipment and Personal Protective Measures

• Biological Safety Cabinets (BSCs): classes, certification, and use

• PPE selection and usage protocols

• Maintenance and calibration of containment equipment

• Hands-on Exercise: BSC operational assessment and PPE inspection checklist

Module 5: Safe Handling, Storage, and Transport of Infectious Materials

• Classification and packaging requirements for infectious substances

• IATA and WHO transport regulations

• Chain of custody and documentation standards

• Hands-on Exercise: Simulating specimen packaging and labeling procedures

Module 6: Waste Management and Decontamination Procedures

• Biological waste segregation and treatment methods

• Chemical disinfection and autoclaving protocols

• Spill management and emergency containment

• Hands-on Exercise: Developing a biosafety waste management plan

Module 7: Incident Reporting, Emergency Response, and Contingency Planning

• Reporting systems for biosafety incidents and near misses

• Emergency response structure and drills

• Communication and coordination during biological events

• Hands-on Exercise: Conducting a tabletop emergency response simulation

Module 8: Biosecurity Risk Management and Dual-Use Research

• Differentiating biosafety and biosecurity

• Insider threats, access control, and pathogen accountability

• Ethical considerations in dual-use research of concern (DURC)

• Hands-on Exercise: Developing a biosecurity risk mitigation plan

Module 9: Biosafety Audits, Inspections, and ISO 35001 Compliance

• Biosafety audit process, checklists, and reporting

• Documentation review and corrective action tracking

• Accreditation and certification requirements

• Hands-on Exercise: Performing a mock biosafety audit and presenting findings

Module 10: Case Study – Comprehensive Biosafety Management System Evaluation

• Reviewing institutional biosafety programs

• Identifying systemic gaps and improvement opportunities

• Integrating biosafety and biosecurity within quality management systems

• Hands-on Exercise: Case study presentation audit report for a reference lab